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warnings and cautions
5 WARNINGS AND PRECAUTIONS Renal disease and electrolyte disorders: Use caution in severe renal impairment and those taking concurrent medications that increase risk, ensure adequate hydration, and consider laboratory assessments prior to and after use. ( 5.1 , 7.1 ) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 ) Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold. ( 5.3 , 7.1 ) Suspected GI obstruction or perforation: Rule out diagnosis before administration. ( 4 , 5.4 ) Colonic mucosal ulceration: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. Use with caution in patients with an acute exacerbation of chronic inflammatory bowel disease ( 5.5 ) Patients at risk for aspiration: Observe during administration. ( 5.6 ) Hypersensitivity reactions, including anaphylaxis : Inform patients to seek immediate medical care if symptoms occur. ( 5.7 ) 5.1 Renal Disease, Acute Phosphate Nephropathy, and Electrolyte Disorders Renal Disease and Acute Phosphate Nephropathy There have been rare, but serious, reports of renal failure, acute phosphate nephropathy, and nephrocalcinosis in patients who received oral sodium phosphate products, including OsmoPrep, for colon cleansing prior to colonoscopy. These cases often resulted in permanent impairment of renal function and several patients required long-term dialysis. The time to onset is typically within days; however, in some cases, the diagnosis of these events has been delayed up to several months after the ingestion of these products. Patients at increased risk of acute phosphate nephropathy may include patients with the following: hypovolemia, baseline kidney disease, increased age, and patients using medicines that affect renal perfusion or function [such as diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and possibly nonsteroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions ( 7.1 )] . Electrolyte Disorders Bowel preparations, including OsmoPrep can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures and renal impairment [see Adverse Reactions ( 6.2 )] . Patient Management OsmoPrep is contraindicated in patients with a history of acute phosphate nephropathy [see Contraindications ( 4 )]. Use OsmoPrep with caution in patients with severe renal impairment (creatinine clearance less than 30 mL/minute), with conditions, or who are taking medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of arrhythmias, seizures, or renal impairment. Consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and BUN) in these patients [see Drug Interactions ( 7.1 )] . Correct electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia before treatment with OsmoPrep [see Dosage and Administration ( 2.1 )] . Avoid additional sodium phosphate-based purgative or enema products [see Drug Interactions ( 7.1 )] . Advise all patients to hydrate adequately before, during, and after the use of OsmoPrep [see Dosage and Administration ( 2.1 , 2.2 )] . If a patient develops significant vomiting or signs of dehydration while or after taking OsmoPrep, consider performing post-colonoscopy lab tests [electrolytes, creatinine, and blood urea nitrogen (BUN)]. 5.2 Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. QT prolongation with sodium phosphate tablets has been associated with electrolyte imbalances, such as hypokalemia and hypocalcemia. Use caution when prescribing OsmoPrep for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy) and those taking medications known to prolong the QT interval, since serious complications may occur. Consider pre-dose and post-colonoscopy ECGs s in patients at increased risk of serious cardiac arrhythmias. 5.3 Seizures There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of sodium phosphate osmotic laxative products, such as OsmoPrep, in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Use OsmoPrep with caution in patients with a history of seizures and in patients at higher risk of seizure, such as patients taking medications that lower the seizure threshold (such as tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions ( 7.1 )]. 5.4 Use in Patients with Significant Gastrointestinal Disease If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering OsmoPrep [see Contraindications ( 4 )] . Use with caution in patients with severe active ulcerative colitis. 5.5 Colonic Mucosal Ulceration and Inflammatory Bowel Disease Osmotic laxatives, including OsmoPrep, may induce colonic mucosal aphthous ulcerations. In the OsmoPrep clinical program, aphthous ulcers were observed in 3% of patients who took the recommended OsmoPrep dosing regimen. Consider the potential for mucosal ulcerations resulting from bowel preparation when interpreting colonoscopic finding should in patients with known or suspected inflammatory bowel disease. Use OsmoPrep with caution in patients experiencing an acute exacerbation of chronic inflammatory bowel disease as published data suggest that sodium phosphate absorption may be enhanced in such patients. 5.6 Aspiration Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of OsmoPrep. Observed these patients during administration of OsmoPrep. 5.7 Hypersensitivity Reactions OsmoPrep may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and throat tightness [see Adverse Reactions ( 6.2 )] . Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.